A Study of Minimally Invasive Surgical Strategies for Robot-assisted Supratentorial Large Hematoma

Nanjing University

Status: Not yet enrolling

Conditions: Hematoma Brain

Treatments: Procedure: Robot-assisted minimally invasive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06484374

SQ2023AAA030147

Details and patient eligibility

About

The AI robot is used to design precise coordinates and access routes for hypertensive cerebral hemorrhage patients with large supratentorial hematomas in conjunction with imaging data, to clarify the therapeutic efficacy of robotic-assisted endoscopic debridement of precise minimally invasive surgical system for perioperative and long-term functional recovery of supratentorial hematomas, and to ultimately achieve the improvement of prognosis for this group of patients, and to alleviate the economic burdens on the society and the families

Full description

In this randomized controlled study, we investigated the efficacy of robotic assistance for supratentorial large hematomas by comparing robotic-assisted minimally invasive removal of supratentorial large hematomas with conventional surgical hematoma removal. Our main comparisons were the 6-month mortality rate and good prognosis rate, and the main evaluation indexes included mRS score and GOS score.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who were diagnosed by imaging (CT, CTA, etc.), measured by the ABC/2 method, and clearly recognized as having a supratentorial hypertensive cerebral hemorrhage.

   Patients with hematoma volume >30mL and GCS score ≥5;

2. The patient's age is 18-70 years old; Patients aged 18-70 years;

3. Time from onset to surgery ≤72h;

4. Repeat CT scan at least 6 hours after the diagnostic CT scan showed that the hematoma was stable;

5. SBP <180 mmHg was recorded near the time of random assignment;

6. mRS score ≤1 in the past medical history;

7. Patient/family informed and signed informed consent.

Exclusion criteria

1. The hematoma is not located on the curtain or the volume of the hematoma is less than 30 ml;
2. The onset of the disease is more than 3 days at the time of admission; Secondary cerebral hemorrhage (secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism).
3. secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism);
4. Presence of serious immune diseases (e.g., cirrhosis, malignant tumors, rheumatic immune diseases, etc.);
5. Poor compliance or inappropriate for enrollment as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Craniotomy

Sham Comparator group

Description:

Traditional craniotomy, by opening the skull and thus removing the hematoma

Treatment:

Procedure: Robot-assisted minimally invasive treatment

Robot-assisted minimally invasive treatment

Experimental group

Description:

Minimally invasive hematoma removal with robotic assistance

Treatment:

Procedure: Robot-assisted minimally invasive treatment